Employs logMAR based and Farnsworth-Munsell 100 Hue testing. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

Change in average 24-hour incontinence [ Time Frame: At 0, 4, 10 and 14 weeks ] [ Designated as safety issue: No ]

The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

The Incontinence - Quality of Life questionnaire is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

The Whittington Urgency Score is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

The Kurtzke EDS assessment is undertaken at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

The Multiple Sclerosis Impact Scale is administered at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

The The Multiple Sclerosis Functional Composite assessment is undertaken at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

The Multiple Sclerosis Walking Scale is assessed at the beginning and end of each four week treatment phase. The change is calculated as the value at the later time point minus the value at the earlier time point for weeks 0 to 4 and weeks 10 to 14 respectively.

Patients with marked bladder dysfunction as a result of secondary progressive multiple sclerosis are being recruited to receive AIMSPRO or placebo by subcutaneous injection, in this double-blind crossover study.

Detailed Description

Treatment periods of 4 weeks' duration are separated by a 6 week wash-out phase. After 14 weeks of randomised therapy there is a 38 week period of "open-label" AIMSPRO treatment.

Ongoing corticosteroid therapy or any corticosteroids within the previous 3 months.

History of known allergy to animal proteins, tuberculosis.

Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections such as acute upper respiratory tract infection or simple urinary tract infection, should be followed to their conclusion or treated, as appropriate, prior to inclusion.

Presence of a transplanted organ, with the exception of a corneal transplant > 3 months prior to screening.

Lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.

Recent clinically significant substance abuse (drug or alcohol).

Poor tolerability of venipuncture.

Investigational drugs or drugs targeted at reducing TNF are not allowed during participation in the study.

Patients will not be permitted to receive immunosuppressive treatment during this study. The exception will be where a patient's treating neurologist determines that a course of steroid therapy, oral or intravenous, is required in view of a sufficiently disabling relapse of MS.

Immunosuppressive therapy within the month prior to entry into the study.

Taking the licensed anticonvulsant medication lamotrigine or the anti-arrhythmic drug flecainide, both of which are potent sodium channel blocking agents.

Unable to fill in the criteria related to bladder dysfunction status.

Unable to give written informed consent.

Use of intermittent or indwelling urinary catheter.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects